Study of the Value of Using a Honey Dressing Compared to the Use of a Standard Dressing on the Toe Amputation Wound in the Diabetic Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Epidermization rate at 6 months.
研究概览
简要总结
Numerous scientific publications in France and internationally have described the healing, anti-bacterial, anti-oxidant, anti-inflammatory and immuno-modulating properties of honey.
Honey is effective in the management of many infected or uninfected post-surgical wounds.
This study focuses on post surgical wounds after toe amputation in diabetic patients.
The main objective of this study is to compare the rate of epidermisation at six months for these wounds, between honey dressing and other dressing devices used according to the french Haute Autorité de Santé (HAS) recommendations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic patients
- •Patients who have had an amputation of one or more toes within four days prior to inclusion without having the second dressing rehabilitated
- •Written informed consent.
排除标准
- •Known hypersensitivity to honey, hyaluronic acid, guar gum, pectin and/or zinc oxide.
- •Insipid Diabètes
- •patient eligible for a dressing by Vacuum Assisted Closure therapy (VAC therapy)
- •transmetatarsal amputation
- •Patient with sutured wound
- •Patient already included in the study, for a previous amputation for wich the wound has not healed.
- •Failure to comply with protocol requirements
- •Person protect by article L1121-5 to L1121-8 of the French Health Public.
- •Patient include in an other clinical study
研究组 & 干预措施
HAS dressing
Patients included in the "HAS dressing" arm will receive the best available dressing according to the HAS recommendations. HAS is the french National Authority for Health (HAS) .
干预措施: HAS recommendation dressing (Device)
Honey dressing
the honey used in this study is the Melectis G dressing. This is a combination of thyme honey (99.8%) and hyaluronic acid (0.2%).
The patient will benefit from the honey dressing until complete healing and/or until the end of the study (maximum 12 months).
干预措施: Honey dressing Melectis G (Device)
结局指标
主要结局
Epidermization rate at 6 months.
时间窗: 6 months after amputation
the relative difference between the volume of the wound in mm3 during the first rehabilitation of the post-operative dressing (J0) and this volume six months after (M6), on the volume of the wound in mm3 at J0. (TM6 = (VD0 - VM6) /VD0)
次要结局
- Epidermization rate at 12 months(12 months after amputation)
- pain during dressing change: verbal scale of pain(inclusion, 1month, 2 months, 3months, 4months, 5 months, 6 months,7months,8months, 8months ,9months 10months, 11months, 12 months after amputation up to cicatrization)
- average length of wound cicatrization(from date of amputation until the date of the first documented complete cicatrization, assessed up to 12 months)
- the satisfaction of professionals for the use of honey dressing(12 months after amputation or at study completion, whichever came first)
- Epidermization rate at 1 month(1 month after amputation)
- Epidermization rate at 2 months(1 month after amputation)